RxSight, Inc. · 10 hours ago
Project Engineer
Aliso Viejo,CA,US
Full-time
Onsite
Mid Level
3+ years expRxSight, Inc. is an ophthalmic medical technology corporation that has developed an innovative adjustable intraocular lens. The Project Engineer will be responsible for coordinating cross-functional development and engineering activities to enhance the performance and manufacturability of the RxSight Light Adjustable Lens and its accessories.
BiotechnologyMedical DeviceElectronicsHealthcareEyewearHealth Care
Responsibilities
Partner with R&D to plan and execute development and verification activities for LAL products and processes, including feasibility studies, verification builds, and characterization testing
Serve as a key partner during development, verification, and manufacturing transfer, coordinating feasibility evaluations, pilot and production builds, equipment qualifications, and process validations. Studies may include process verification, biological evaluation, chemical characterization, and other safety and performance studies to verify product quality and performance
Coordinate weekly scheduling of shared R&D processing and testing equipment to support engineering studies and verification builds; negotiate and prioritize equipment, materials, and personnel utilization across teams to meet timelines
Help ensure teams stay on task and on time across all project phases, including requirements collection, project scoping and change descriptions, project planning, execution of studies, management of project deliverables, and project closure
Support evaluation and risk assessment of proposed changes including assessing technical need and strategic fit
Collaborate with cross functional teams to develop integrated project plans, maintain and track project timelines, monitor progress, and identify issues, risks, and mitigation actions
Collect and interpret test results and other technical data, summarize findings, and provide recommendations for next steps
Develop and maintain a structured repository of test results and technical data, ensuring traceability of test articles and results, facilitating data-driven decision-making and enabling efficient retrieval of historical testing results
Draft and drive technical documentation through the quality system, including protocols, reports, change control documentation, and contributions to the risk management file and design history file
Provide concise and accurate status updates to teammates and stakeholders, highlighting accomplishments, upcoming activities, risks, and key decisions
Support preparation of timelines, resource estimates, and budgeting inputs as directed
Ensure work is performed in compliance with applicable quality and regulatory requirements, including ISO 13485 and relevant ISO and FDA standards
Participate in and facilitate cross functional technical meetings, project reviews, standups, and design reviews, documenting decisions and action items and driving closure
Contribute to continuous improvement of project execution and documentation processes by regularly collecting team feedback, identifying gaps, proposing enhancements, and implementing continuous improvements
Qualification
Required
Bachelor's degree in engineering (ideally chemical, biomedical, or materials), chemistry, materials science, or related technical discipline
Minimum of 3-4 years of experience within medical devices or other related life sciences field preferred
Ability to coordinate cross functional technical projects, build practical project plans, and help ensure on time completion of deliverables
Strong organizational skills, with the ability to manage multiple concurrent studies, builds, and documentation packages while maintaining attention to detail
Proficiency in analyzing test data, identifying trends, and connecting results to product performance, safety, and process capability and making informed recommendations
Clear, concise written and verbal communication skills, including experience preparing technical protocols, reports, and summaries for varied audiences
Ability to collaborate effectively with R&D, Operations, Quality, Regulatory, and Supply Chain, maintaining a respectful, constructive, solution oriented working style
Self motivated, proactive, curious, and eagerness to learn and attain mastery of the medical device product lifecycle in a fast-growing, entrepreneurial, novel technology company
Strong desire to develop deep understanding of LAL technology, its performance characteristics, and its manufacturing processes
Ensure work is performed in compliance with applicable quality and regulatory requirements, including ISO 13485 and relevant ISO and FDA standards
Preferred
Minimum of 3-4 years of experience within medical devices or other related life sciences field preferred
Working knowledge of medical device quality and regulatory frameworks is a plus, including familiarity with design controls and risk management, and familiarity with key ISO standards and FDA regulations relevant to medical device testing
Familiarity with good manufacturing practices (GMP) and good documentation practices (GDP). Experience with good laboratory practices (GLP) is a plus
Project Management software is a plus (SmartSheet preferred)
Business Intelligence software is a plus (Power BI preferred)
Quality management system software is a plus
Company
RxSight, Inc.
RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery.
201-500 employees
H1B Sponsorship
RxSight, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$350.98MKey Investors
Oxford Finance LLCBiomedical Advanced Research and Development Authority (BARDA)Visionary Venture Fund
2024-05-08Post Ipo Equity· $115M
2023-02-07Post Ipo Equity· $50M
2021-07-29IPO
Leadership Team
Ron Kurtz
Co-President and CEO
R
Robert Grubbs
Co-Founder
Recent News
Orange County Business Journal
2026-01-22
2026-01-20
Orange County Business Journal
2026-01-14
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